Preventing Obstetric Complications With Dietary Intervention

NCT ID: NCT06320054

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-12
• Study Completion Date: 2026-12-31

Brief Summary

The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are:

• Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns?
• Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups.

Participants in the standard of care will be asked to:

• Complete surveys
• Biometric screenings

Participants in the intervention group will be asked to:

• Complete surveys
• Biometric screenings
• Participate in weekly personal health coaching
• Receive and consume provided weekly meals.

Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth.

Conditions

Gestational Diabetes; Gestational Hypertension; High Risk Pregnancy; Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard Prenatal Care

Standard Prenatal Care, biometric screenings, and surveys (baseline, 4-12 weeks postpartum).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Maternal Health Management Program

Program participants will receive 10 fresh, local meals each week, delivered to their homes, health coaching including cooking and physical activity, biometrics screenings, and educational support to enable sustainable lifestyle change.

Group Type: EXPERIMENTAL

Maternal Health Management Program

Intervention Type: BEHAVIORAL

Program participants will receive 10 fresh, local meals each week, delivered to their homes, health coaching including cooking and physical activity, biometrics screenings, and educational support to enable sustainable lifestyle change.

Interventions

Maternal Health Management Program

Program participants will receive 10 fresh, local meals each week, delivered to their homes, health coaching including cooking and physical activity, biometrics screenings, and educational support to enable sustainable lifestyle change.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age at enrollment ≥ 18 years of age

2. Receiving prenatal care at Froedtert

3. ≤ 16 weeks and 6 days of gestation

4. At risk of preeclampsia, defined as being eligible for low dose aspirin treatment AND/OR at risk for gestational diabetes defined as having a history of gestational diabetes, OR previously given birth to an infant weighing ≥ 4000 g, OR has a diagnosis of PCOS

5. Pre-pregnancy Body Mass Index ≥ 25 kg/m^2

6. Resides in Milwaukee County at time of consent

7. Low socio-economic status (<200% of FPL defined as receiving Medicaid)

8. Able to read and communicate in English

9. Has access to a smart device/computer with reliable internet connection

10. Has access to a working refrigerator

11. Viable singleton pregnancy

Exclusion Criteria

1. Diagnosed with Type I or Type II Diabetes or Hemoglobin A1C ≥ 6.5%

2. Diagnosed with End Stage Renal Disease

3. Use of weight-increasing psychotropic agents

4. Active inflammatory bowel disease, or history of bowel resection or malabsorptive syndrome, or history of bariatric surgery

5. Significant food allergies, preferences or dietary requirements that would interfere with diet adherence

6. Multifetal gestation

7. Active substance use that would preclude program adherence

8. Chronic use of oral corticosteroids

9. Unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Advancing a Healthier Wisconsin Endowment

UNKNOWN

Sponsor Role: collaborator

Food for Health, Inc.

UNKNOWN

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Anna Palatnik, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Palatnik, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedert & The Medical College of Wiscosin

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anna Palatnik, MD

Role: CONTACT

Phone: 414-805-6624

Email: apalatnik@mcw.edu

Amandla Stanley, MSN

Role: CONTACT

Phone: 414-805-6691

Email: akstanley@mcw.edu

Facility Contacts

Anna Palatnik, MD

Role: primary

Other Identifiers

PRO00049771

Identifier Type: -

Identifier Source: org_study_id